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Pfizer's Prevnar 13 Vaccine Effective in Adults, FDA Says

By Anna Edney

Nov. 14 (Bloomberg) -- Pfizer Inc.’s Prevnar 13 vaccine for a bacterial infection that can cause pneumonia is safe and effective in adults ages 50 and over, a population that could add almost $2 billion to sales in 2015.

Prevnar 13 has been shown to be acceptable in adults who have received Merck & Co.’s older vaccine approved almost 30 years ago and those never immunized, according to a Food and Drug Administration staff report released today. An FDA advisory panel is set to meet to consider the safety and efficacy of the shot Nov. 16.
The vaccine’s use in adults “is a very lucrative opportunity” for Pfizer, the world’s largest drugmaker,
Catherine Arnold, an analyst with Credit Suisse Group AG in New York wrote Oct. 21 in a note to clients. She estimated total 2015 sales at $5.9 billion with adult use contributing $1.8 billion. The vaccine was approved in the U.S. in 2010 for children who are six weeks old through 5 years of age.

FDA considers the protection of adults from pneumococcal pneumonia a “meaningful therapeutic benefit over existing treatments,” according to the report.

No major safety concerns were found, though limitations included the size of the safety database, which may be too small to detect some rare adverse events, the report said.

Pfizer fell 1.1 percent to $19.78 at 11:15 a.m. New York time. The shares were up 14 percent this year before today.

Pneumococcal pneumonia accounts for 175,000 hospitalizations each year in the U.S. and more than 6,000 deaths, according to the National Foundation for Infectious Diseases.

Immune Response

Pfizer examined patients’ immune systems’ response to the vaccine. FDA is weighing approval based on the condition the company studies the vaccine further to prove it protects against pneumococcal pneumonia. Prevnar 13 sales in the first nine months of this year totaled $2.82 billion, according to company filings.

Pfizer conducted clinical studies that showed the vaccine likely will be associated with better protection than Whitehouse Station, New Jersey-based Merck’s Pneumovax 23 against pneumococcal pneumonia, Emilio Emini, Pfizer’s chief scientific officer for vaccine research, said in a telephone interview. The basis is the body’s ability to remember an encounter with Prevnar 13, unlike Merck’s product, making booster shots with Pfizer’s product more effective, Emini said.
Testing showed people who have had Merck’s vaccine can use Prevnar 13. Pneumovax 23 brought in $276 million in sales in the first nine months of this year, according to company filings.

Insurance Coverage

Insurance coverage will depend on whether the Centers for Disease Control and Prevention’s vaccines panel recommends Prevnar 13 for those 50 and older. The 2010 health law requires coverage of vaccines recommended by the panel without a co-payment or deductible cost to patients.

Merck’s vaccine is recommended for people ages 65 and older and for people 2 years and older at high risk such as those with sickle cell disease, HIV infection and other conditions that compromise the immune system, according to the CDC. It is also recommended for adults 19 to 64 years old who smoke, have asthma or live in nursing homes or long-term care facilities.

Recommendations

“Those recommendations then translate into the professional medical society recommendations and it’s the professional medical society recommendations that physicians will look at in recommending vaccines to their patients,” Emini said.

Pfizer is discussing Prevnar 13 with the vaccines panel and would likely make its first formal presentation in February after the FDA’s Jan. 2 decision date on whether to expand the vaccines use to adults, he said.

Pfizer has started an 85,000-subject trial in the Netherlands to attempt to confirm Prevnar 13’s effectiveness versus those who don’t receive a vaccination, Emini said. The company also is studying when adults should receive booster shots. He said Prevnar works well at intervals of 3 1/2 years or
four years so Pfizer is examining a five-year booster to make it easy to remember when to vaccinate again.